gabapentin

Generic: gabapentin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 400 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-198
Product ID 71610-198_2b488923-8b9b-c828-e063-6394a90ad0cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204989
Listing Expiration 2026-12-31
Marketing Start 2016-02-18

Pharmacologic Class

Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610198
Hyphenated Format 71610-198

Supplemental Identifiers

RxCUI
310432
UNII
6CW7F3G59X
NUI
N0000008486

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gabapentin (source: ndc)
Generic Name gabapentin (source: ndc)
Application Number ANDA204989 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-53)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-60)
  • 180 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-80)
  • 270 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-92)
  • 360 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-94)
source: ndc

Packages (5)

71610-198-53 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-53) 71610-198-60 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-60) 71610-198-80 180 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-80) 71610-198-92 270 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-92) 71610-198-94 360 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-94)

Ingredients (1)

gabapentin (400 mg/1)

Linked Drug Pages (1)

Gabapentin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b488923-8b9b-c828-e063-6394a90ad0cc", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310432"], "spl_set_id": ["13b87441-8fe1-40f5-8ffb-00dcd8cc90a6"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-53)", "package_ndc": "71610-198-53", "marketing_start_date": "20200730"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-60)", "package_ndc": "71610-198-60", "marketing_start_date": "20181214"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-80)", "package_ndc": "71610-198-80", "marketing_start_date": "20181214"}, {"sample": false, "description": "270 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-92)", "package_ndc": "71610-198-92", "marketing_start_date": "20201217"}, {"sample": false, "description": "360 CAPSULE in 1 BOTTLE, PLASTIC (71610-198-94)", "package_ndc": "71610-198-94", "marketing_start_date": "20181128"}], "brand_name": "Gabapentin", "product_id": "71610-198_2b488923-8b9b-c828-e063-6394a90ad0cc", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-198", "generic_name": "Gabapentin", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "400 mg/1"}], "application_number": "ANDA204989", "marketing_category": "ANDA", "marketing_start_date": "20160218", "listing_expiration_date": "20261231"}